Clinical trial · Observational
Low Dose Radiotherapy in Primary Indolent Cutaneous B-cell Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Primary indolent cutaneous B cell lymphomas (PCBCL) are rare: although data on outcomes and treatment are limited, traditionally they have been treated with radiation doses in excess of 24 Gy. Recently, some trials that patients with primary cutaneous indolent lymphoma managed with very low dose (4 Gy) RT (LDRT) have shown that high response rates and durable remission can be achieved; unfortunately, given the retrospective nature of these studies, the role of LDRT in indolent PMCL remains undefined. The objective of this retrospective multicentric trial is to investigate the efficacy of low-dose involved-field radiation therapy in patients with primary indolent cutaneous B-cell Lymphoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Primary Indolent Cutaneous B-cell Lymphoma | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Local Progression-Free Interval in Irradiated Field
- timeFrame
- 12 months
- description
- Time from the start of low dose radiotherapy (LDRT) to tumor progression within the irradiated field
Secondary outcomes (6)
- measure
- Acute toxicity
- timeFrame
- 4 weeks
- description
- The occurence and severity of acute adverse events (toxicities)
- measure
- Late toxicity
- timeFrame
- 12 weeks
- description
- The occurrence and severity of late adverse events (toxicities)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age greater than or equal to 18 years * Histological diagnosis of indolent B-cell lymphoma (follicular, marginal, NOS) * Primary cutaneous location * Early stage (I-II) * First diagnosis or recurrence * Low-dose radiotherapy treatment (4 Gy/2 sessions) Exclusion Criteria: * Aggressive histology lymphomas * Advanced stages * Extracutaneous localisation * Radiotherapy dose administered \> 4 Gy * Patients without histological typing * Patients without follow-up
References
Publications (6)
- BACKGROUNDChristensen L, Cooper K, Honda K, Mansur D. Relapse rates in patients with unilesional primary cutaneous B-cell lymphoma treated with radiation therapy: a single-institution experience. Br J Dermatol. 2018 Nov;179(5):1172-1173. doi: 10.1111/bjd.16783. Epub 2018 Jul 27. No abstract available. PMID 29761874
- BACKGROUNDSenff NJ, Noordijk EM, Kim YH, Bagot M, Berti E, Cerroni L, Dummer R, Duvic M, Hoppe RT, Pimpinelli N, Rosen ST, Vermeer MH, Whittaker S, Willemze R; European Organization for Research and Treatment of Cancer; International Society for Cutaneous Lymphoma. European Organization for Research and Treatment of Cancer and International Society for Cutaneous Lymphoma consensus recommendations for the management of cutaneous B-cell lymphomas. Blood. 2008 Sep 1;112(5):1600-9. doi: 10.1182/blood-2008-04-152850. Epub 2008 Jun 20. PMID 18567836
- BACKGROUNDWillemze R, Cerroni L, Kempf W, et al. The 2018 update of the WHO-EORTC classification for primary cutaneous lymphomas. Blood. 2019;133(16):1703-1714. Blood. 2019 Sep 26;134(13):1112. doi: 10.1182/blood.2019002852. No abstract available. PMID 31558559
- BACKGROUNDWillemze R, Hodak E, Zinzani PL, Specht L, Ladetto M; ESMO Guidelines Committee. Primary cutaneous lymphomas: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2018 Oct 1;29(Suppl 4):iv30-iv40. doi: 10.1093/annonc/mdy133. No abstract available. PMID 29878045
- BACKGROUNDNicolay JP, Wobser M. Cutaneous B-cell lymphomas - pathogenesis, diagnostic workup, and therapy. J Dtsch Dermatol Ges. 2016 Dec;14(12):1207-1224. doi: 10.1111/ddg.13164. PMID 27992127
- BACKGROUNDDippel E, Assaf C, Becker JC, von Bergwelt-Baildon M, Beyer M, Cozzio A, Eich HT, Follmann M, Grabbe S, Hillen U, Klapper W, Klemke CD, Lamos C, Loquai C, Meiss F, Mestel D, Nashan D, Nicolay JP, Oschlies I, Schlaak M, Stoll C, Vag T, Weichenthal M, Wobser M, Stadler R. S2k Guidelines - Cutaneous Lymphomas Update 2016 - Part 1: Classification and Diagnosis (ICD10 C82 - C86). J Dtsch Dermatol Ges. 2017 Dec;15(12):1266-1273. doi: 10.1111/ddg.13372. Epub 2017 Nov 28. No abstract available.